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Aczone

Generic name: dapsone
Treatment for: Acne

Atrix and Fujisawa Submit New Drug Application for Acne Product

FORT COLLINS, Colo., September 01, 2004 -- Atrix Laboratories, Inc. (NASDAQ:ATRX) announced today that on August 31, 2004, together with co-development partner Fujisawa Healthcare, Inc., they submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Aczone Gel 5% (dapsone topical gel), formerly called Atrisone, for the treatment of acne vulgaris.

"We are excited about the submission of this NDA for Aczone," said David R. Bethune, Atrix's chairman and chief executive officer. "We are proud of the extraordinary hard work, commitment, and dedication of the ACZONE development team, made up of representatives from both Atrix and Fujisawa. The submission of this NDA illustrates the ability of the team to put together complex NDAs and meet the timelines associated with this challenging task."

Aczone uses Atrix's proprietary Solvent Microparticle (SMP(TM)) delivery system to deliver dapsone, a water-insoluble compound with anti-inflammatory and anti-microbial properties. Dapsone currently is only commercially available for other indications as an oral tablet for systemic delivery due to the compound's water insolubility. Atrix's SMP system allows localized delivery of this drug. The North American market for topical acne products is over $800 million.

Fujisawa Healthcare, Inc., the North American subsidiary of Fujisawa Pharmaceutical Co., Ltd., in a co-development agreement, has licensed the marketing rights to Aczone for the treatment of acne vulgaris and has provided significant support for the development of the product and submission of the NDA.

Hideo Fukumoto, chairman and chief executive officer of Fujisawa Healthcare, Inc., said, "We are excited about this important milestone, and the prospect of adding Aczone to our dermatology portfolio."

Atrix Laboratories, Inc. is an emerging specialty pharmaceutical company focused on advanced drug delivery. With unique sustained release and topical technologies, Atrix is currently developing a diverse portfolio of proprietary products, including oncology, and dermatology products. The company also partners with large pharmaceutical and biotechnology companies to apply its proprietary technologies to new chemical entities or to extend the patent life of existing products.
Fujisawa Healthcare, Inc., headquartered in Deerfield, Illinois, develops, manufactures and markets proprietary pharmaceutical products in the United States and abroad. Fujisawa Healthcare, Inc. is a subsidiary of Fujisawa Pharmaceutical Co., Ltd., based in Osaka, Japan. Fujisawa Pharmaceutical Co., Ltd., founded in 1894, is a leading pharmaceutical manufacturer and is actively developing its international operations in North America, Europe and Asia.
On April 1, 2005, Astellas Pharma, Inc. will be created with the merger of Fujisawa Pharmaceutical Co., Ltd. and Yamanouchi Pharmaceutical Co, Ltd., subject to relevant regulatory clearances.

Posted: September 2004

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